Actuate Therapeutics Announces ASCO Poster Presentations Demonstrating Compelling Clinical And Biomarker Data For Elraglusib In First-Line Metastatic Pancreatic Cancer

(MENAFN- GlobeNewsWire - Nasdaq) - Patients with KRAS wild-type (WT) genomics achieved significant improvement in median overall survival (mOS) when treated with elraglusib plus gemcitabine/Abraxane (GnP) versus GnP alone

- Patients with P53WT genomics receiving elraglusib plus GnP showed a near doubling of mOS versus GnP alone

- Patients receiving elraglusib plus FOLFIRINOX demonstrated deep and sustained clinical responses and increased mOS versus FOLFIRINOX alone or in combination with losartan

- Elraglusib treatment was well tolerated when used in combination with either GnP or FOLFIRINOX

CHICAGO and FORT WORTH, Texas, June 01, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, today announced that two presentations were given at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentations featured post-hoc efficacy and biomarker analyses from the randomized Phase 2 study (NCT03678883 ), along with clinical data from a Phase 2 study conducted at Mass General Brigham Cancer Institute of elraglusib in combination with FOLFIRINOX (FFX) and the TGF-β inhibitor losartan in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

“The consistency of the survival benefit, the depth and durability of responses, and the favorable safety profile observed across studies with both gemcitabine/Abraxane and FOLFIRINOX continue to underscore the broad clinical promise of elraglusib in combination with established chemotherapy regimens,” said Daniel Schmitt, President & Chief Executive Officer of Actuate.“We believe these data further strengthen the positioning of elraglusib as a potentially differentiated backbone therapy and expand future development opportunities in key patient populations across multiple combination settings. The potential to combine with RAS/RAF/MEK inhibitors in patients where those therapies would be appropriate, along with significant survival benefit in patients without those molecular mutations, speaks to the broad therapeutic potential of elraglusib. Looking ahead, the planned addition of our oral formulation should enable broader combination strategies, greater dosing flexibility, and expanded clinical and commercial potential.“

Title: Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma
First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist and Professor of Medicine at Northwestern University Feinberg School of Medicine

A comprehensive post-hoc efficacy and biomarker analysis of the randomized Phase 2 1801 Part 3B study showed that elraglusib plus gemcitabine/nab-paclitaxel (GnP), compared with GnP alone, provided meaningful clinical benefit across multiple patient subgroups in previously untreated mPDAC.

Key Findings from the Analysis

• Striking survival advantages of elraglusib/GnP vs GnP alone were observed in patients with wild-type (WT) tumor genomics:
  • Patients with KRAS WT treated with elraglusib/GnP achieved a mOS of 16.9 vs 10.1 months (p<0.001), a nearly 7-month improvement.
  • This survival advantage was consistent across key tumor suppressor gene subgroups analyzed:
    • TP53 WT: 13.4 vs 7.6 months, (p=0.002)
    • CDKN2A WT: 10.4 vs 7.6 months, (p=0.002)
    • SMAD4 WT: 10.1 vs 7.1 months, (p=0.003)
• Positive OS trends were observed in both the intent-to-treat (ITT) and modified intent-to-treat (mITT) populations treated with elraglusib plus GnP versus GnP alone.
• In a landmark analysis of patients completing at least one treatment cycle, mOS was approximately 12.5 months in the elraglusib/GnP arm compared with 8.5 months in the GnP control arm, with a near doubling of the one-year survival rate versus GnP alone.
• Exploratory subgroup analyses demonstrated improved OS in patients treated with elraglusib/GnP vs GnP who had:
  • ECOG performance status of 0 (12.2 vs 8.0 months; p=0.007)
  • Baseline albumin ≥3 g/dL (10.8 vs 7.6 months; p=0.02)
  • Baseline CA19-9 <8000 U/mL (12.2 vs 7.8 months; p=0.01)
  • Lower tumor grade (Grade 1+2, 14.3 vs 7.8 months, p=0.005)
• Lower tumor mutational burden, lower circulating tumor DNA (ctDNA) fraction, and lower tumor grade were correlated with improved survival outcomes only in elraglusib/GnP-treated patients, providing a foundation for prospective patient selection in future studies.

Title: A Phase II Study of FOLFIRINOX (FFX) Combined with the Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor Elraglusib (ELRA) and the Transforming Growth
Factor-β (TGF-β) Inhibitor Losartan (LOS) in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

First Author: Priyadarshini Pathak, Mass General Brigham Cancer Institute, Boston, USA

The Phase 2 study evaluated elraglusib in combination with FFX and losartan (LOS) across four treatment arms in a first-line population of patients with mPDAC.

Key Findings

• Arms incorporating elraglusib demonstrated meaningful improvement: elraglusib/FFX and elraglusib/FFX+LOS each achieved mOS of 9.8 months and mPFS of 6.0 and 6.5 months, respectively, vs 7.7 months and PFS of 5.1 with FFX alone.
  
• A subset of patients in elraglusib combination arms demonstrated deep and durable responses, with ongoing biomarker analyses evaluating features associated with long-term benefit.
  
• The combination was generally well tolerated. Grade 3 or higher treatment-related adverse events occurred in 34.7% of patients, with the most common being diarrhea, fatigue, hypokalemia, and decreased platelet count, a profile consistent with the known toxicities of FOLFIRINOX, further supporting the tolerability of elraglusib.

The posters are available on the Actuate Therapeutics website.

About Actuate Therapeutics, Inc.

Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate's lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function.

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Forward-Looking Statements

This press release contains forward-looking statements about us, including our and other parties' clinical trials and development plans, and our industry. The words“anticipate,”“believe,”“continue,”“could,”“estimate,”“expect,”“intend,”“may,”“might,”“ongoing,”“plan,”“potential,”“predict,”“project,”“should,”“target,”“will,”“would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies, early clinical trials and sub-group studies are not necessarily predictive of future results and may not correlate with improved responses, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond July 2026, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading“Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, and our Quarterly Reports on Form 10-Q, and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

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